European Pharmaceutical Contractor

Summer 2012

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Marketplace & Business

Business Management

Big Pharma in Crisis?

Despite the challenges the industry currently faces, Big Pharma is looking for new ways to render the drug development process more efficient and sustainable, as Chris Swain of Cambridge MedChem Consulting discusses.

UK Survey

Life Science Expectancy

Nick Stephens at RSA explores the results of the UK Life Science Industry Leaders Survey, highlighting disappointment at the Government’s lack of support for the industry and the areas with potential for growth.

Pain Management Therapeutics

In Search of Relief

With an ageing population and promising new treatments in the pipeline, the pain management market is set to continue its growth. Swapna Soni at GBI Research highlights the key trends in this sector.

Clinical Trials

Strategic Outsourcing: Clinical Trial Management

Changing Landscapes

Outsourcing the management of a clinical trial can prove to be a beneficial strategy. Tom Avery at ERT considers the pros and cons of such an approach, with reference to respiratory therapeutics and ePRO.

Regional Trials: Asia

Find your Partner

As Asia continues to grow as a centre for international drug development, it can be useful to consider the benefits
of working with a local CRO, as Young Jack Lee at LSK Global PS discusses.

Feasibility Studies

Weighing up the Options

Alexandra Terzakis at SIRO Clinpharm suggests that a feasibility study is essential to the success of a clinical trial, incorporating regulatory considerations, patient recruitment expectation and any anticipated costs.

Early Phase Trials: Oncology

Starting Blocks

As the field of oncology drug development continues to grow, Jane Bentley at Novella Clinical explores the best way to optimise Phase 1 clinical trials, from improving protocol preparation to monitoring data.

Legal & Regulatory

Obesity Drug Development: FDA Guidance

The Heart of the Matter

Regina M Ballinger at Thomson Reuters provides an overview of the obesity drug market, and considers the regulatory guidance in relation to a number of potential new drugs in the pipeline.

Observational Studies: Regulatory Considerations

Seeing Clearly

Providing real-world data for decision making, non-interventional studies (NIS) must still adhere to the relevant regulations. Rohini Chari at United BioSource Corporation explores the key considerations for setting up an NIS.

US Pedigree Laws

Patchwork Approach?

US drug pedigree laws were established in order to combat the rise in counterfeit drugs. Dirk Rodgers of RxTrace.com examines these regulations and suggests that they need to go much further in order to ensure supply chain integrity.

Drug Development & Delivery

Drug Development: Virtual R&D

A New Dimension

Karyn Korieth at CenterWatch investigates the development of new virtual research companies, which seek to overcome declines in productivity by adopting radical new methods for R&D.

Greater involvement in the CRO-sponsor relationship, coupled with a consideration of the technology involved in research, can help both parties to remain competitive, as Graham Bunn at Medidata Solutions Worldwide explains.

Cool Chain, Labs & Logistics

Supply Chain: Outsourcing

Turning Tide

Outsourcing logistics activities need not be as daunting a task as many pharmaceutical companies perceive it to be. Fabio Mioli at DHL Supply Chain discusses the benefits of working with a specialist supply logistics service provider.

In Conclusion

Paying the Price

Graham Hughes considers the industry’s approach to drug pricing.

Medical Writing

Regulatory Submissions

Re-Writing the Rule Book

Outsourcing the process of writing regulatory documents provides reliable expertise, flexibility and cost-efficiency, as James Sawyer at Prism Ideas explores.

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News and Press Releases

2019 IPEC Europe Annual Excipients Forum, Malta, 31 January

Join NSF at this dynamic conference in Malta on the 31st January 2019, recognised to be one of the key events for pharmaceutical excipients in Europe.
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Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.More info >>

The World Advanced Therapies & Regenerative
Medicine Congress is an exhibition and conference that has grown to become one
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The 2019 edition will be in its 14th year and it continues to grow and attract
a large audience of biotech, pharma, start-ups, investors, research and
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host over 1000 attendees, 250 speakers and 80 exhibition booths. Over 500
different global companies are represented every year at this event. More info >>